Label: KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF- pyrithione zinc lotion

  • NDC Code(s): 63766-004-01, 63766-004-02
  • Packager: Avlon Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 29, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

    Active Ingredient                                                                              

    Pyrithione Zinc 0.2%

    Purpose

    Anti-Dandruff

  • INDICATIONS & USAGE

    Use for the relief of flaking, itching and irritation Associated with dandruff.

    -----------------------------------------------------------------------------------------------------

  • Warnings

    ■ For external use only

    -----------------------------------------------------------------------------------------------------

  • Ask a doctor if

    ■ Condition worsens or does not improve with regular use.

    -----------------------------------------------------------------------------------------------------

  • WHEN USING

    When using this product

    ■ Avoid getting into eyes. In event of contact, rinse eyes thoroughly with water.

    -----------------------------------------------------------------------------------------------------

  • STOP USE

    Stop use and ask a doctor if

    ■ Condition worsens or does not improve with regular use.

    -----------------------------------------------------------------------------------------------------

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact

    a Poison Control Center right away.

    -----------------------------------------------------------------------------------------------------

  • Directions

    • Apply daily or several times a day as needed.
    • Massage gently into scalp.
    • Do not rinse out.

    -----------------------------------------------------------------------------------------------------

  • Inactive Ingredients

    Water/Aqua/Eau, Mineral Oil, Petrolatum, Beeswax, Cetyl Alcohol, Lanolin, Sodium Borate, Polysorbate 60,

    Polysorbate 80, Carthamus Tinctorius (Safflower) Seed Oil, Eugenia Caryophyllus (Clove) Flower Extract,

    Glyceryl Stearate, Menthol, Sulfur, Perfume, BHT, Methylisothiazolinone, A-Isomenthyl Ionone, Benzyl Alcohol,

    Benzyl Benzoate, Benzyl Cinnamate, Benzyl Salicylate, Butylphenyl Methylpropional, Cinnamal Alcohol, Citronellol,

    Geraniol, Hexyl Cinnamal, Hydroxycitronellal, Hydroxyisohexyl 3-cyclohexane Carboxaldehyde, d-Limonene, Linalool.

  • SPL UNCLASSIFIED SECTION

    ©2014 Manufactured by Avlon Industries, Inc.,

    1999 N. 15th Avenue, Melrose Park, IL 60160 USA

    77 Oxford Street, London, W1D 2ES, UK  www. Avlon.com

  • Package Label. Principal Display Panel

    KeraCare® Anti-Dandruff Spot Itch Lotion controls itching and dandruff in between weekly

    services. Best dandruff defense when used in conjunction with KeraCare Dry & Itchy Scalp

    Moisturizing Shampoo and Conditioner.

    l labelspotitchlotion_samplelabelspotitchlotion_2oz

  • INGREDIENTS AND APPEARANCE
    KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF 
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63766-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LANOLIN (UNII: 7EV65EAW6H)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CLOVE (UNII: K48IKT5321)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MENTHOL (UNII: L7T10EIP3A)  
    SULFUR (UNII: 70FD1KFU70)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63766-004-0160 mL in 1 TUBE; Type 0: Not a Combination Product06/18/2009
    2NDC:63766-004-027.5 mL in 1 POUCH; Type 0: Not a Combination Product06/18/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03206/18/2009
    Labeler - Avlon Industries, Inc. (121278626)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avlon Industries, Inc.121278626manufacture(63766-004)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!